This reform also allows for a pathway for marketing approval of biosimilar medicines, by including The Biologics Price Competition and Innovation (BPCI) Act of 2009, which established an abbreviated Biologic License Application (aBLA) pathway for the approval of biosimilars.

However, according to marketing analysis group inThought—part of Wolters Kluwer Pharma Solutions, the aBLA pathway may never be used.

At the Business of Biosimilars meeting in Boston, USA, in September 2010, developers of both innovator and generic biological, as well as representatives from the scientific, regulatory, and legal communities, noted that, because of unclear requirements for clinical data and the need for public disclosure of proprietary data, manufacturers of generic biologicals are unlikely to take advantage of the aBLA process, opting instead for a standard Biologic License Application (BLA).

InThought believes that companies will still develop follow-on biologics, but approved compounds will behave as new branded drugs and not biosimilars. This will mean that the loss of revenue due to generic entry of a typical biological molecule would be around 30% over five years compared to 90% for a typical branded small molecule.

This cannot be good news for the FDA as they have already invested some time and effort into implementing the BPCI Act and creating a biosimilars guideline. The agency has already set up the Biosimilar Implementation Committee and has put in place two biosimilar review committees; the Center for Drug Research and Evaluation and the Center for Biologics Evaluation and Research.

The agency also held a two-day public meeting in November 2010 to gain input on the act’s implementation from interested parties (including the public, healthcare professionals and manufacturers).

Whatever the means of registration, biosimilars can only be good news for governments and patients alike – even a 30% reduction in cost is not to be sniffed at!

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